Attorneys at Schlichter, Bogard & Denton file Yasmin/Yaz lawsuit

Date Released: 07/24/2009 St. Louis, MO – The attorneys at Schlichter, Bogard & Denton, L.L.P. filed suit this week in Iowa federal court against Bayer alleging that Bayer’s oral contraceptives Yasmin and Yaz are defective and present an increased risk of injury to women. Their client represents her daughter who at the age of 23 died suddenly of multiple bilateral pulmonary embolisms after using Yaz for only 8 months. The client’s daughter was engaged to marry her high school sweetheart. She had also just graduated from college and was to start her first post-graduation position a scant three days after her sudden death. An avid swimmer, plaintiff’s daughter was named to an All American Swim Team three times and gave swim lessons through the American Red Cross. She is survived by her fiancé, parents, two siblings, grandparents, aunts, uncles and cousins.

The lawsuit alleges that Bayer failed to warn the client’s daughter and their physicians of the increased risk of injury, while over-promoting the benefits of the drugs. In October of 2008, the Food and Drug Administration (FDA) sent Bayer a warning letter objecting to its television ads claiming that Yaz has additional benefits compared to other oral contraceptives. The FDA’s letter warned that Yaz actually has additional risks because it contains the progestin drospirenone. The warning prompted an agreement for Bayer to spend $20 million on corrective ads.

Both Yasmin and Yaz have been associated with heart attacks, deep vein thrombosis, pulmonary embolism, stroke and even death in young women.

Schlichter, Bogard & Denton attorneys Roger Denton, Kris Kraft and Beth Wilkins are experienced in litigating dangerous birth control product liability cases. Mr. Denton, Ms. Kraft and Ms. Wilkins are also vigorously litigating suits against the makers of Ortho Evra and NurvaRing in addition to Yasmin/Yaz. Schlichter, Bogard & Denton are lead attorneys on the NuvaRing MDL.

Currently only a handful of Yasmin/Yaz cases across the country have been filed against the manufacturer. Not only are Mr. Denton, Ms. Kraft, and Ms. Wilkins pioneers in these suits across the country, they are also leading their firm’s Yasmin and Yaz litigation and expect to file additional lawsuits in the coming weeks.

Media Contact: Kristine Kraft Schlichter, Bogard & Denton, L.L.P. Phone: 314.621.6115 kkraft@uselaws.com www.uselaws.com

Labels: athlete, Bayer, bilateral pulmonary embolism, death, Deep Vein Thrombosis, DVT, heart attack, Iowa, stroke, YAZ

The U.S. Food and Drug Administration has announced a safety review of Xolair (omalizumab), a drug used to treat moderate-to-severe persistent asthma in adults and adolescents.
Reviewers are looking for a possible association between patients who use Xolair and an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke. The manufacturer’s long term evaluation study’s interim results have suggested an association between using Xolair and these adverse events. The study is being conducted by the manufacturer, San Francisco-based Genentech Inc.
The Early Communication is part of the FDA’s commitment keep the public informed about its ongoing safety reviews of drugs. Though the review focuses on potential adverse events, the FDA is not advising a change in prescribing or use of the drug at this time.
For more information please see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm172399.htm

Labels: Asthma, FDA, Genetech, heart attack, heart failure, heart rhythm, stroke, Xolair

The U.S. Food and Drug Administration has announced a safety review of Xolair (omalizumab), a drug used to treat moderate-to-severe persistent asthma in adults and adolescents.

Reviewers are looking for a possible association between patients who use Xolair and an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke. The manufacturer’s long term evaluation study’s interim results have suggested an association between using Xolair and these adverse events. The study is being conducted by the manufacturer, San Francisco-based Genentech Inc.

The Early Communication is part of the FDA’s commitment keep the public informed about its ongoing safety reviews of drugs. Though the review focuses on potential adverse events, the FDA is not advising a change in prescribing or use of the drug at this time.

For more information please see:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm172399.htm

Labels: Asthma, FDA, Genetech, heart attack, heart failure, heart rhythm, stroke, Xolair

The American Heart Association (AHA) released an advisory that a “clot-busting” drug can be effective for an extra 90 minutes longer than what the FDA has approved the drug for. The drug, called recombinant-tissue plasminogen activator, or rt-PA, is one that can be administered to stroke patients when they enter the hospital and will immediately dissolve clots, possibility preserving patients’ ability to function. The FDA has for the last ten years has set a limit on allowing the drug to only be used within 3 hours of a patient suffering a stroke. The AHA advisory, however, shows that the drug can still be effective on patients if it is administered with 4.5 hours of a patient suffering a stroke.

Rt-PA works almost instantly dissolving clots, which account for more than 85% of strokes. The drug is in effective for the 15% of strokes caused by a burst blood vessel in the brain. Once a stroke patient comes to the emergency room, it can take up to 45 minutes to determine what the cause of the stroke is, often times brining the patient out of the FDA-approved 3 hour window for the drug. A further challenge is getting people to the emergency room on time. Fewer than 25% of people recognize their stroke symptoms soon enough to even get to the hospital in time to be administered the drug.

Using the drug according to the AHA advisory is an off-label use of rt-PA. It is legal to use drugs for an off-label use after the drug has been approved by the FDA, but it is much more risky. This advisory gives doctors that administer the drug past the 3 hour time limit support. The advisory also states that people that aren’t suited for use of the drug after 3 hours are those who are older than 80, those who are on blood thinners for a cardiovascular condition, and those who have diabetes or previous strokes. Barnes-Jewish Hospital has been administering the drug for the extra 90 minute window since the beginning of the year.

For more information, see the St. Louis Post-Dispatch Article at:
http://www.stltoday.com/stltoday/lifestyle/stories.nsf/healthfitness/story/958DD75F122A2F3E862575DF00742BEF?OpenDocument

Labels: American Heart Association, Barnes-Jewish, clot-buster, FDA, rt-PA, stroke

Middle-aged adults who get too little sleep are more likely to develop high blood pressure. Missing just one hour of sleep a night over five years raises risk of high blood pressure by 37 percent.

"People who didn't sleep as much were at greater risk of developing hypertension over five years," Kristen Knutson of the University of Chicago reported in the Archives of Internal Medicine on Monday.

Adults typically should sleep between seven and nine hours a night, according to the U.S. Centers for Disease Control and Prevention.

Sleeping too little has different negative health affects depending on age. In children, lack of sleep has been shown to raise rates of obesity, depression and high blood pressure. In older adults, it increases the risk of falls. And in the middle-aged, it raises the risk of infections, heart disease, stroke, cancer and high blood pressure.

The team studied 578 adults with an average age of 40. They took blood pressure readings and measured how long each person slept. Only 1 percent slept eight hours or more.

The study participants on average slept six hours. Each hour of lost sleep raised the risk of high blood pressure.

"If you compare six hours of sleep to five hours of sleep, the five-hour sleepers will have 37 percent greater odds of developing hypertension," Knutson said.

Men, especially African American men, slept less then Caucasian women.

"These two observations suggested the intriguing possibility that the well-documented higher blood pressure in African Americans and men might be partly related to sleep duration," Knutson and colleagues wrote.

Please see: http://archinte.ama-assn.org/cgi/content/short/169/11/1055

Labels: 6 hours, cancer, despression, fungal infections, heart disease, high blook pressure, kate cooper, obesity, Sleep, snore, stroke

The risk of risperdal and stroke in patients with dementia-related psychosis is serious enough to warrant a black box label. Risperdal has not be shown to be a safe or effective treatment of patients with dementia-related psychosis.

In a letter to healthcare providers dated April 2003, Janssen Pharmaceuticals, the maker of risperidone, described adverse event reports that prompted the label revision: "Cerebrovascular adverse events (eg, stroke, transient ischemic attack), including fatalities, were reported in patients in trials of risperidone in elderly patients with dementia-related psychosis." The controversial aspect of this Risperdal stroke announcement was the fact that Johnson & Johnson had already issued a Canadian Risperdal stroke letter in October 2002. The Canadian Risperdal stroke warnings cited 37 reports of Risperdal stroke or Risperdal stroke-like events, including 16 deaths. Physicians in the United States were not warned until another 5 months had passed.

In addition, a significantly higher incidence of cerebrovascular adverse events was seen in patients treated with Risperdal compared with those treated with placebo. This label update was based on data from a study of 1,230 patients with dementia in four placebo-controlled trials conducted in elderly patients with dementia. Janssen emphasized in the letter that Risperdal is not indicated for the treatment of dementia.

The implications that Risperdal stroke occurrences are more likely to occur should result in a higher accountability for prescribing Risperdal.

Many patients are concerned that Johnson and Johnson is not promptly warning the FDA and/or their physicians of serious events such as Risperdal strokes over concerns that safety warnings will hurt sales.

The result of a Risperdal stroke can affect the entire body. Depending on the severity of the Risperdal stroke paralysis, cognitive effects, emotional problems, speech difficulties, loss of mobility, in addition to other adverse effects could be suffered. If you or a loved one has taken Risperdal and have suffered a Risperdal stroke or any other Risperdal side effect, then please contact our attorneys who can assist you with asserting your legal rights and seeking recovery for the injuries you have suffered.

For more information: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm152291.htm

Labels: Black box label, Canada, dementia, Risperdal, Stoke, stroke

We have previously posted about some of the dangers of the Yaz birth control pill. Even more information has come out since. Yaz has recently been under heavy scrutiny for possible dangerous side effects such as stroke, pulmonary embolism, and deep vein thrombosis (DVT). Additionally, the FDA and many states’ attorney general have been on Yaz’ case for a different problem: misleading advertising.

The first time Yaz was admonished for misleading the public was through an FDA warning letter in 2003. The letter was in regards to misleading ads that stated that Yaz was “unique” because it contained progestin drospirenone, therefore leading people to believe that Yaz was superior to other birth control pills. Then in 2008, the FDA sent another warning letter concerning two separate television commercials that publicized treatments for which Yaz was not approved. In February of 2009, attorney generals from 27 different states reached a settlement with Yaz to correct misleading information that Yaz put in tv ads that suggested that Yaz was approved for the treatment of PMS and acne. As a result, Yaz is now required to get FDA approval for all ads before they can air on tv.

Yaz was first released in May 2001 and has since become one of the best selling oral contraceptives, with sales over $616 million in 2008. Neither the FDA nor the manufacturer, Bayer, have yet to recall the drug for its serious side effects. Many of the people that take Yaz may have been induced to take it through Yaz’s misleading advertising, and in turn, suffering serious side effects.

For more information, see:
The FDA’s warning letter concerning Yaz:
http://origin.www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm053993.pdf

Wall Street Journal article concerning new ad campaign:
http://www.nytimes.com/2009/02/11/business/11pill.html

Labels: advertising, Air France, birth control, DVT, FDA, NCAA, stroke, Susan Boyle, YAZ

YAZ is the first birth control pill to combine 20 mcg of ethinyl estradiol (EE) with the so-called "fourth generation" progestin drospirenone (DRSP). Fourth generation progestin drospirenone has antimineralocorticoid properties, which means that it can work against the body's normal mechanism for regulating salt and water balance, a situation that can lead to hyperkalemia in high risk patients, resulting in potentially serious heart and health problems. YAZ was approved by the FDA in March 2006.
A company press release, "FDA Approves YAZ(R), The First Oral Contraceptive To Offer Drospirenone In A 24-Day, Active-Pill Regimen", regarding approval of the drug suggests cardiovascular events are not a concern when using YAZ. The press release states:
YAZ contains 3 mg of the progestin drospirenone that has antimineralocorticoid activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25-mg dose of spironolactone. YAZ should not be used in patients with conditions that predispose to hyperkalemia (i.e., renal insufficiency, hepatic dysfunction, or adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium should have their serum potassium levels checked during the first treatment cycle. Medications that may increase serum potassium include ACE inhibitors, angiotensin-ll receptor antagonists, potassium-sparing diuretics, potassium supplementation medications, aldosterone antagonists and NSAIDs.
In YAZ’s current package insert, the warning above is bolded while serious cardiovascular side effects like deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, and stroke are not emphasized.
The FDA now has some concerns about an association between YAZ and DVT, PE, heart attack, and stroke as demonstrated in the International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC) study.
WebMD even lists blood clots such as pulmonary embolism, stroke or heart attacks as rare but very serious side effects of using YAZ.
There are numerous reports of women suffering from a DVT or a PE while using YAZ pills.
The safety concerns surrounding YAZ are similar to the serious and at times fatal side effects of unsafe birth control like Ortho Evra and NuvaRing.
For more information please see: http://www.fda.gov/medwatch/SAFETY/2007/Jan_PI/Yaz_PI.pdf,
http://origin.www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm053993.pdf
http://www.medicalnewstoday.com/articles/39844.php, http://clinicaltrials.gov/ct2/show/NCT00335257,
http://www.webmd.com/drugs/mono-656-ETHINYL+ESTRADIOL%2FDROSPIRENONE+24%2F4+-+ORAL.aspx?drugid=95358&drugname=YAZ+28+Oral,

Labels: birth control, cardiovascular, death, Deep Vein Thrombosis, DVT, heart attack, PE, pulmonary embolism, stroke, YAZ

Hundreds of women throughout the country are the victims of serious injuries caused by the NuvaRing. They have suffered strokes and blood clots, and many of them died. 150 or more women or their families have filed lawsuits against Organon, the maker of the NuvaRing, for the injuries and deaths it has caused.

The NuvaRing is a vaginal contraceptive ring that provides monthly birth control by inserting it against the cervix. It uses a type of synthetic hormone that is different from the one used in traditional birth control pills and is more dangerous.

If you or someone you love has been hurt by the NuvaRing, you may be entitled to compensation. Contact the expert attorneys at Schlichter, Bogard & Denton for a free consultation.

nuvaring@uselaws.com
nationalinjuryattorneys@uselaws.com
314-621-6115

For more information, see the following links:

Woman warns others not to use NuvaRing

Schering-Plough, Akzo Nobel sued over NuvaRing contraceptive device

Wrongful Death Lawsuit Filed Over NuvaRing

Labels: attorney, birth control, blood clot, contraception, death, DVT, lawyer, Nuva Ring, NuvaRing, stroke, thrombosis